Eli Lilly and Co.; Announcement of the Revocation of the Biologics License for LARTRUVO, 43587 [2020-15516]
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Federal Register / Vol. 85, No. 138 / Friday, July 17, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1618]
Eli Lilly and Co.; Announcement of the
Revocation of the Biologics License
for LARTRUVO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the revocation of the
biologics license application (BLA) for
LARTRUVO (olaratumab) injection. Eli
Lilly and Co. requested withdrawal
(revocation) of the biologics license
application and has waived its
opportunity for a hearing.
DATES: The BLA is revoked as of
February 25, 2020.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137.
SUPPLEMENTARY INFORMATION: On
October 19, 2016, FDA approved the
BLA for LARTRUVO (olaratumab)
injection held by Eli Lilly and Co. (Eli
Lilly), Lilly Corporate Center,
Indianapolis, IN 46285, indicated, in
combination with doxorubicin, for the
treatment of adult patients with soft
tissue sarcoma with a histologic subtype
for which an anthracycline-containing
regimen is appropriate and which is not
amenable to curative treatment with
radiotherapy or surgery, under the
Agency’s accelerated approval
regulations at 21 CFR part 601, subpart
E. On January 18, 2019, Eli Lilly
reported in a press release that the
confirmatory study required as a
condition of LARTRUO’s accelerated
approval, entitled ‘‘Randomized,
Double-Blind, Placebo-Controlled,
Phase 3 Trial of Doxorubicin Plus
Olaratumab Versus Doxorubicin Plus
Placebo in Patients With Advanced or
Metastatic Soft Tissue Sarcoma’’
(ANNOUNCE trial), ‘‘did not meet the
primary endpoints of overall survival in
the full study population or in the
leiomyosarcoma subpopulation.’’ On
September 27, 2019, Eli Lilly requested
withdrawal (revocation), in writing, of
the BLA for LARTRUVO (olaratumab)
injection (BLA 761038) under § 601.5(a)
(21 CFR 601.5(a)) because the
ANNOUNCE trial failed to demonstrate
improvement in overall survival for
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SUMMARY:
VerDate Sep<11>2014
18:12 Jul 16, 2020
Jkt 250001
olaratumab in combination with
doxorubicin compared to doxorubicin
alone. In that letter, Eli Lilly waived its
opportunity for a hearing. On February
25, 2020, the Agency issued a letter to
Eli Lilly revoking the approval to
manufacture and market LARTRUVO
(olaratumab) injection (BLA 761038).
Therefore, under § 601.5(a), the
Agency revoked the BLA for
LARTRUVO (olaratumab) injection
(BLA 761038), applicable as of February
25, 2020.
Dated: July 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–15516 Filed 7–16–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1647]
Science Advisory Board to the
National Center for Toxicological
Research Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Science Advisory Board (SAB) to the
National Center for Toxicological
Research (NCTR). The general function
of the committee is to provide advice
and recommendations to the Agency on
research being conducted at the NCTR.
At least one portion of the meeting will
be closed to the public.
DATES: The meeting will be held on
August 18, 2020, from 8 a.m. to 5:55
p.m. (CST), and on August 19, 2020,
from 8 a.m. to 11:30 a.m. (CST).
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm. The meeting will be
webcast both days and will be available
at the following link: https://
collaboration.fda.gov/nctr1000/.
FOR FURTHER INFORMATION CONTACT:
Donna Mendrick, National Center for
Toxicological Research, Food and Drug
SUMMARY:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
43587
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 2208, Silver Spring,
MD 20993–0002, 301–796–8892, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On August 18, 2020, the SAB
Chair will welcome the participants,
and the NCTR Director will provide a
Center-wide update on scientific
initiatives and accomplishments during
the past year. The SAB will be
presented with an overview of the SAB
Subcommittee Site Visit Report and a
response to this review. The Center for
Biologics Evaluation and Research,
Center for Drug Evaluation and
Research, Center for Devices and
Radiological Health, Center for Food
Safety and Applied Nutrition, Center for
Tobacco Products, and Office of
Regulatory Affairs will each briefly
discuss their specific research strategic
needs and potential areas of
collaboration.
On August 19, 2020, there will be
updates from the NCTR Research
Divisions and a public comment
session. Following an open discussion
of all the information presented, the
open session of the meeting will close
so the SAB members can discuss
personnel issues at the NCTR at the end
of the day.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: On August 18, 2020, from
8 a.m. to 5:55 p.m., and on August 19,
2020, from 8 a.m. to 11:30 a.m. (CST),
E:\FR\FM\17JYN1.SGM
17JYN1
]]>Agencies
[Federal Register Volume 85, Number 138 (Friday, July 17, 2020)]
[Notices]
[Page 43587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15516]
[[Page 43587]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1618]
Eli Lilly and Co.; Announcement of the Revocation of the
Biologics License for LARTRUVO
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the revocation of the biologics license application (BLA) for LARTRUVO
(olaratumab) injection. Eli Lilly and Co. requested withdrawal
(revocation) of the biologics license application and has waived its
opportunity for a hearing.
DATES: The BLA is revoked as of February 25, 2020.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.
SUPPLEMENTARY INFORMATION: On October 19, 2016, FDA approved the BLA
for LARTRUVO (olaratumab) injection held by Eli Lilly and Co. (Eli
Lilly), Lilly Corporate Center, Indianapolis, IN 46285, indicated, in
combination with doxorubicin, for the treatment of adult patients with
soft tissue sarcoma with a histologic subtype for which an
anthracycline-containing regimen is appropriate and which is not
amenable to curative treatment with radiotherapy or surgery, under the
Agency's accelerated approval regulations at 21 CFR part 601, subpart
E. On January 18, 2019, Eli Lilly reported in a press release that the
confirmatory study required as a condition of LARTRUO's accelerated
approval, entitled ``Randomized, Double-Blind, Placebo-Controlled,
Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus
Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma''
(ANNOUNCE trial), ``did not meet the primary endpoints of overall
survival in the full study population or in the leiomyosarcoma
subpopulation.'' On September 27, 2019, Eli Lilly requested withdrawal
(revocation), in writing, of the BLA for LARTRUVO (olaratumab)
injection (BLA 761038) under Sec. 601.5(a) (21 CFR 601.5(a)) because
the ANNOUNCE trial failed to demonstrate improvement in overall
survival for olaratumab in combination with doxorubicin compared to
doxorubicin alone. In that letter, Eli Lilly waived its opportunity for
a hearing. On February 25, 2020, the Agency issued a letter to Eli
Lilly revoking the approval to manufacture and market LARTRUVO
(olaratumab) injection (BLA 761038).
Therefore, under Sec. 601.5(a), the Agency revoked the BLA for
LARTRUVO (olaratumab) injection (BLA 761038), applicable as of February
25, 2020.
Dated: July 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15516 Filed 7-16-20; 8:45 am]
BILLING CODE 4164-01-P
